Logilab SDMS solution for Eudralex Annex 11 Compliance requirements
Principle
Requirement
This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.
The application should be validated; IT infrastructure should be qualified. Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process
Logilab SDMS Approach
Logilab SDMS is the computerized system which has been developed with the required functionalities. It is a a generic software application designed to handle scientific instrument data from any analytical instrument and can facilitate data management with access control. Logilab SDMS will perform scheduled data capture, cataloguing, archival and facilitate restoring data and has capabilities to extract data of interest from instrument output to be pushed to external systems like Electronic Note Book (ELN), Laboratory Information Management System (LIMS) and Enterprise Resources Planning (ERP). It is intended to improve the product and service quality and reduce the overall risk.
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